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ILUVIEN® Implant for Diabetic Macular Edema (NEW DAY Trial)
NEW DAY Trial Summary
This trial is testing whether or not a new treatment for DME is better than the standard treatment. It will enroll patients who have not had any DME treatments for the past 12 months, and compare the new treatment to the standard treatment.
NEW DAY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNEW DAY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NEW DAY Trial Design
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Who is running the clinical trial?
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- I have or had high eye pressure, glaucoma, or a significant eye condition.I am 18 years old or older.I have not had certain eye treatments in the past year.I have cataracts or similar conditions that affect my vision and daily activities.I have had LASER eye therapy but not in the macula area.My vision in the study eye is somewhat impaired but not severely.I have conditions that could cause swelling in the back of my eye.My eye condition is due to advanced diabetic retinopathy.
- Group 1: Aflibercept Arm
- Group 2: ILUVIEN Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still open for this clinical research project?
"Affirmative. Clinicaltrials.gov displays that this investigation is presently recruiting participants, and was first announced on August 31st 2020 until January 4th 2022. Three hundred people are desired across 38 sites for the trial's duration."
Has any prior research been conducted with Aflibercept Arm?
"The Aflibercept Arm was initially studied in 2014 at the M D Anderson Cancer Center, with 256 trials having been successfully completed. Currently, 49 live trials are ongoing; a notable concentration of them based out of Erie, Pennsylvania."
How many individuals have been recruited to participate in this investigation?
"Affirmative, the information posted on clinicaltrials.gov displays that this experiment is still recruiting participants. It was first advertised August 31st 2020 and has since been updated January 4th 2022. To reach its goal of 300 patients, it is actively looking across 38 sites nationwide."
How widely distributed is this research in Canada?
"Participants in this medical trial can currently be recruited from 38 different sites. These locations span Erie, Bloomfield and Houston as well as a selection of other cities. It is advantageous to recruit the closest site to reduce travel requirements for those involved."
What medical issues has Aflibercept Arm been shown to address?
"Aflibercept Arm is primarily leveraged in the treatment of diabetic macular edema (dme). This medication can also be employed to manage conditions such as friction and pressure injuries, otitis media, and bacterial skin inflammation."
Has the FDA issued a sanction for Aflibercept Arm?
"The safety rating of Aflibercept Arm was determined to be 3, as this treatment has been approved and is currently in Phase 4 trials."
Who else is applying?
What portion of applicants met pre-screening criteria?
What site did they apply to?
Why did patients apply to this trial?
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